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Head of Quality and Compliance

2 months ago

Oxford, Oxfordshire, United Kingdom Planet Pharma Full time

Job Title: Head of Quality Assurance

Job Type: Permanent

Location: Hybrid

About the Role:

We are seeking a highly experienced and skilled Head of Quality Assurance to join our team at Planet Pharma. As a key member of our organization, you will be responsible for developing and leading the QA function to ensure the highest standards of quality and compliance.

Key Responsibilities:

  • Develop and Implement Quality Strategy: Lead the quality planning process to create a quality strategy that aligns with the company's goals and objectives.
  • Quality Management System (QMS): Develop, implement, and oversee the company's QMS to ensure compliance with applicable GMP, GDP, GLP, GCP, and GPvP guidelines.
  • Electronic QMS Solutions: Manage the implementation and operation of electronic QMS solutions as required.
  • Risk-Based Approach: Establish a risk-based approach for the supervision and monitoring of GxP-related activities, including the development of a governance framework with relevant metrics and measurements.
  • Quality Management Review: Lead the Quality Management Review process.
  • Vendor Management: Implement and oversee a vendor management program for the qualification and monitoring of GxP vendors.
  • GxP Audit Program: Manage the GxP audit program and conduct audits as needed.

Requirements:

  • Experience: Significant experience in the development, manufacturing, and quality control of sterile pharmaceuticals.
  • Regulatory Experience: Experience engaging with regulatory agencies (such as FDA, EMA, or national EU agencies), including managing inspections, attending scientific meetings, and addressing review questions.
  • Quality Management Systems: Demonstrated expertise in designing, implementing, and managing Quality Management Systems.
  • Leadership Experience: Experience leading a team of QA professionals to deliver high-quality outcomes for the organization.